LIMS & EDMS in Quality


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LIMS & EDMS in Quality

  1. 1. Customer Case Study:Water, Environmental andPharma LIMS Solution TransformsInformation Management Solutionat Nova BiologicalsEstablished in 1993, Nova Biologicals, Inc. is one of the leading full-service, NELAC accred-ited laboratories in Texas, providing laboratory testing and consulting services to the water,medical device, pharmaceutical, neutraceutical and food industries globally. As a full-servicetesting laboratory, Nova is dedicated to serving the many needs of its customers throughsuperior service, a committed staff, and its investment in research and development.Prompted by increasing government solution set. The company selected the Federal Safe Drinking Water Act. Therequirements and compliancy demands Thermo Scientific LIMS, integrated with company works closely with municipalities,Nova needed to change its way of work- NextDocs DMS – implemented as one, municipal utility districts, water controling in order to comply with its State of cohesive solution in its Texas facility. and improvement districts, drinking waterTexas license. Nova’s history of proactively vending companies and federal and stateseeking solutions to customer and regula- Company Background regulatory authorities to ensure safe watertory requirements prompted its search for Nova is one of the nation’s largest providers that has the trust of its consumers.better ways to provide excellent customer of water testing for drinking and wastewater Water testing makes up 53% of Nova’sservice. As such, it identified information and has provided nationwide testing services total revenue. Coliform testing makes up themanagement in its laboratory as a solution to the industry, specializing in microbiologi- largest percentage of tests with approximate-to future-proof the business. Nova also cal, chemical and toxicological testing. Nova ly 10,000 water samples being processed onrecognized the need to move from its time- provides comprehensive diagnostic testing a monthly basis, all of which is undertakenconsuming, manual, paper-based processes of specimens for the presence of infectious in a single laboratory. Over the last tento a fully automated, versatile and efficient disease organisms and water testing under years, Nova has expanded the microbiologyPart of Thermo Fisher Scientific
  2. 2. portion of the business (environmental, medical and food Business Challenges and System Requirementsrelated) testing for or against organisms. Organizations involved in water and environmental Nova has been servicing its many customers, primar- processing have additional needs to automate manual andily in North America, but also in Africa, Asia, Canada, paper processes, increase sample throughput and improvethe UK and Italy, for more than 15 years. The company efficiencies, all while enhancing customer satisfaction andattributes its very low client turnover to its dedication to ensuring compliancy with the ever-growing demands ofservice and responsiveness. industry regulations. Meeting these needs can be hugely time consuming and expensive, especially for private labs who also need to package and report quality control infor- mation which is vital for sending to clients. One such solution to these growing challenges is a Laboratory Information Management System (LIMS). LIMS have become much more prevalent and neces- sary in testing facilities as demand and regulations have grown and paper based systems are no longer effective. A LIMS works by scheduling and holding sampling plans, which are then used to generate a collection run for each sampler. The collection run defines where samples must be taken from, what sample bottles must be collected and what onsite tests have to be performed. Samples are then analyzed in the laboratory and water quality data, as well as details of what has been carried out in the field, is entered into LIMS. This is important as water companiesLab Accreditation and Compliance: Growing must collect and analyze their water samples in a closelyRequirements for Water and Environmental Labs regulated environment, maintaining complete quality con-Standards for environmental testing in laboratories have trol records in case of inspection or audits.become more rigorous and far reaching over the last Prior to implementing the Thermo Scientific andfew years as new requirements have been introduced via NextDocs solution, Nova managed its work using paperNELAP and EPA regulations. The regulations provide that was supported by an out-dated laboratory infor-a set of protocols outlining what is acceptable regard- mation system. The laboratory system had significanting the daily processes within a multi-disciplinary water deficiencies in that it only allowed entry of Coliformlaboratory in accordance with internationally accepted data and had limited reporting capabilities. Continuedstandards. Meeting these stringent requirements for Water use would not sustain Nova’s growing business inand Environmental samples has introduced labor intensive microbiology, medical device and pharmaceutical testing.procedures to ensure compliance, such as sample tracking, In addition, since the old system was located on oneChain of Custody (COC), record keeping, Demonstration computer, only one employee could use the system at aof Capability (DOC), document control, reagent and stan- time, which created bottlenecks in the laboratory anddard traceability, proof of training and reporting. significantly limited the volume of samples that could be Assessed against the provisions of the 2003 NELAC processed in a given day.standard and the Texas Department of State Health After the State of Texas adopted NELAC standards,Services (TDSHS), Nova is a NELAP accredited laboratory. Nova recognized that it needed to make changes to itsIt is also FDA registered and designated by the FDA as a current process or find a more advanced system thatprivate laboratory and complies with the FDA’s GLP would support its growing and future needs. Nova choseand GMP requirements. the latter and commissioned a consultant to help draw up requirements for the vendor selection process. The system needed to be user-friendly, easily maintained and NELAP stands for the National Environmental Laboratory configurable, web-based, support flexible functionality, capable of complex reporting requirements and meet all of Accreditation Program and is the program that implements its regulatory requirements (GLP, GMP, NELAC, HIPAA, the National Environmental Accreditation Conference (NELAC) etc.). The new system had to be able to: standards. State and federal agencies serve as accrediting • entralize all data in a single database that would C authorities with coordination facilitated by the EPA to support multiple departments across the site assure uniformity. Accreditation by one NELAP accrediting • Configure and extend with ease authority is mutually recognized by the other state and • rack the status and workflow throughout the lab T federal accrediting authorities approved under NELAP. State lifecycle from submission to final analysis programs are in place to certify the labs, making sure that • utomate processes to eliminate timely error-prone A quality protocols are in place and ensuring a standardized set redundant data entry processes and paper trails of processes are implemented and followed. • e accessible by multiple users both internally to B Nova and with external customers
  3. 3. • anage documents such as SOPs and training M speed”. During and following the implementation, everyone records for audit purposes and traceability was cross trained and understood the system and how to • asily and efficiently migrate data to and from E use it, so user adoption and acceptance was easy. What was customers. a perceived challenge in fact turned out to be very beneficial to the company.Vendor SelectionNova took a very inclusive approach to the vendor Ability to Manage Sample Fluctuationselection process, with the whole team listening to The nature of sample testing means that there are peaksthe vendor presentations and scoring them against a and valleys and some months, such as quarterly statepredetermined list of criteria. Based on employee votes, reporting deadlines, are much busier than others. Novathe Thermo Fisher Scientific and NextDocs solution set may have as many as 1,500 Coliform samples to processstood well above the competition. Dr. Pearce, CEO and in one day and in the past it was a struggle to manageFounder of Nova says, “The Thermo Fisher presentation these volumes because of the limited accessibility to theand demo was based on our actual needs. They took the legacy system. The old system was located on one com-time to find out about our company and what we were puter so only one employee could use the system at a time.looking for—they went beyond what we asked for in This created bottlenecks in the laboratory and significantlythe RFP. For example, during the discovery phase they limited the volume of samples that could be processeduncovered the fact that document management was one of in a given day. With SampleManager, as many as fiveour key challenges and tailored their solution accordingly. people can process samples at any one time—which meansThey brought NextDocs into the discussion and completely that Nova can now process very high sample volumesintegrated their Document Management Systems (DMS) in a short period of time when necessary. Furthermore,with their LIMS”. WebAccess means that users can access the system from Another key factor in the selection process was find- any computer as long as they have a web a system that was versatile. “Microbiology is not likechemistry which is primarily based on numbers.” explainsDonna Reioux, Quality Manager, Nova. “An organism canbe unpredictable so a system needs to be more able to copewith variables, many of which cannot be anticipated. Wefelt that the Thermo Scientific LIMS and NextDocs integrat-ed solution gave us what we needed—a highly configurablesystem that could meet our current and future needs”. In addition, Nova was also aware of Thermo Fisher’sreputation as a leading provider of LIMS solutions to thewater and environmental industry. For more than 25 years,Thermo Fisher has effectively controlled the processes oflarge water and environmental companies worldwide withrigorous testing and real-time monitoring so they came witha proven track record.BenefitsNova is delighted with the benefits that the new solutionhas brought to fruition, many of them being tangiblebenefits that were anticipated and some of them that werenot anticipated. It has been instrumental in helping Novamaintain its NELAC accreditation in the state of Texas,refine work processes and improve reporting to custom-ers in terms of quality and speed. The implementationconsisted of Thermo Scientific SampleManager LIMS andNextDocs DMS. Implementation was carried out by bothvendors as one seamless supplier to provide a completesolution to facilitate compliance. Efficiency, Quality and Personnel Cost Savings There was a perceived challenge around employees With five members of the staff being able to login samplesadapting to a new way of working that was quickly real- at the same time, staff bottlenecks have been eliminated,ized to be a strength. Says Donna Reioux, “Many of our saving many man hours across the company. In addition,upper management and lab technicians have worked here significant improvements in efficiencies and data qualityfor 7 or 8 years–we have a very low staff turnover–so have been achieved with the systems automation, built-inunderstandably there was a sense of ‘we’ve always done document management capabilities and report generationit this way, why do we have to change?’. With anything and distribution it takes a little time for people to gain confidence and
  4. 4. Information about rejected samples had to be supplied to customers on a daily basis. Previously this was reported manually, whereas the LIMS allows rejected sample data to be entered and the customer can access this informa- tion daily as part of their report. By eliminating this daily manual process, scientists are able to concentrate on more value-added activities and process higher volumes of work. Improved Customer Service and Responsiveness Superior customer service is a cornerstone of Nova’s success and SampleManager enables them to provide their clients with more meaningful information and data. For example, reporting on sample trends, patterns and volumes is some- thing Nova has always been keen to do, but is now greatly facilitated by SampleManager’s ease of access to informa- tion and capabilities. This adds commercial opportunities to Nova’s portfolio as the company can tailor reports to indi- vidual customer requirements, offering a bespoke reporting format to a wider customer base. The Nova team is proud of its ability to handle a huge range of requirements from companies that operate all over the globe, requiring different information to be reported. “We have some very unique and specific customer require-Improved Knowledge Continuity ments” comments Dr. Pearce, “but now I feel that we canPreviously, the system was run by one or two people meet any requests since the system is so extensible.”at Nova who knew everything and this meant that thebusiness was potentially at risk if they left. With the Ease of Auditing and Regulatory Compliancenew system, not only are more people now trained, Auditing can take place sporadically, sometimes there canbut with SampleManager in place, the support from be only one in six months and then three in a month. Thethe Thermo Scientific team means that the Nova will old paper-based system made audits time-consuming andhave no problems if one or two key members of the onerous. Now, because everything is stored in chronologi-team were to leave. They are no longer relying on a home- cal order with dedicated authorized folders sorted intogrown system and now have the additional benefit and months and years, the whole process of auditing is muchconfidence that the continuity of Thermo Fisher Scientific easier and records are automatically updated. Managers cansupport brings. also now review records weekly instead of monthly making One of the unforeseen cost savings Nova benefited internal auditing more efficient.from is the fact that any laboratory analyst, regardless Auditing of training documentation is particularly keyof the department they work in, are now able to receive and this is where NextDocs is invaluable to Nova, allow-deliveries on a Saturday and enter the samples in the ing automatic updating of customer training records intoLIMS. Previously, water department personnel were NextDocs. All Standard Operating Procedures (SOPs) arerequired to be scheduled on a Saturday along with an loaded and when staff members are trained this is recordedanalyst to accept and enter samples into LIMS. NowNova is able to save one or two days of resource fromeach month’s payroll since staff have been cross trainedand are comfortable with the system.Reduced Paper TrailThe LIMS and DMS have helped Nova to significantlyreduce the amount of paperwork used in its processes andmethodologies. It has automated and accelerated processeswithin the company from sample collection to results andreport generation, saving time and reducing costs throughimproved production efficiencies. The solution has helpedto eliminate manual error-prone processes, improve dataquality and save substantial amounts of time. Furthermore,secure access to sample data is available for laboratorystaff, remote users and external customers, enabling allsystem users to view the same information and ensuringconsistency and clarity.
  5. 5. in the system. This information can be easily pulled out – In addition to thesethere are links within SampleManager to this information Nova is FDA registered (Registration offices, Thermo Fisher In addition to these– and again this leads to higher confidence and speed where Number 1641521) and is designated by the Scientific maintains offices, Thermo Fisherauditing is concerned and demonstrates compliance with FDA as a private laboratory and complies a network of represen­ Scientific maintainsregulations. with the FDA’s GLP and GMP requirements. tative organizations a network of represen­ Nova was audited by the State of Texas for NELAC Nova is certified by the U.S. EPA’s National Environmental throughout the world. tative organizationsAccreditation in March, 2010. “We passed with flying Laboratory Accreditation Program (NELAP) and TDSHScolors!” said Donna Reioux. throughout the world. (TDH) and participates in proficiency testing programs established by MicroCheck. Australia/AsiaFuture PacificNova is in the process of rolling the system out to cover Australia/Asia +61 8 8208 8200 Pacificthe pharmaceutical, neutraceutical, medical device, cos- China +61 8 8208 8200 Thermo Scientific CONNECTS helps customers expandmetic, food, and beverage microbiology testing side of the +86 800 810 5118 the business of science from the laboratory throughout Chinabusiness. This covers approximately 47% of the samples the enterprise. Nova needed a document management France +86 800 810 5118processed. The clients submitting these samples are either solution that was able to be tightly integrated with a +33 160924800 Franceundergoing approval processes through the FDA and/or LIMS and the CONNECTS platform was particularly Germany/Eastern +33 160924800EPA or are conducting lot release testing as required by the appealing to the company. EuropeFDA, EPA, State authorities, and internal quality controls Germany/Eastern +49 6103 408 1110and processes. The types of microbiology testing required Europe About NextDocs India +49 6103 408 1110by Nova’s clients include: testing antibiotics, antimicrobials, NextDocs is the global leader in providing Microsoft +91 22 6742 94 94 Indiaor disinfectants against aerobic and anaerobic bacteria, SharePoint-based document and quality management Latin America and +91 22 6742 94 94yeast, molds, and viruses to determine their inhibitory or solutions to life sciences organizations. It enables busi- the Caribbeankilling effects. Additionally, Nova tests client samples such Latin America and nesses in regulated industries to achieve compliance with +1 781 933 4689 the Caribbeanas raw materials or finished goods in the medical device, FDA and other agencies while automating processes, Netherlands/Benelux +1 781 933 4689cosmetic, food or beverage industries for sterility or the improving efficiency and dramatically reducing costs. +31 76 579 5555absence of aerobic and anaerobic bacteria, yeast, molds, Netherlands/Benelux NextDocs customers include pharmaceutical companies, Spain/Portugaland viruses. According to Donna Reioux, “The building of +31 76 579 5555 bio-techs, medical device companies and CROs. +34 914 845 965these tests is harder; because there are so many variables Spain/Portugal NextDocs has received various awards and also earnedin microbiology, the tests are less predictable. However, at United Kingdom +34 914 845 965 the ISO 9001:2008 certification which is recognizedthe same time, the implementation process will be quicker +44 1619423000 United Kingdom internationally and is the most comprehensive standardbecause I know more now and have total confidence in USA/North America +44 1619423000 in the ISO 9000 series.the system.” +1 800 395 5467 NextDocs is part of Thermo Fisher’s Global Partner USA/North America Alliance Program which connects our clients with market +1 800 395 5467Conclusion leading software and service providers. Together, we deliverThe solution deployed at Nova is an illustration of how the most robust suite of enterprise informatics solutionsThermo Scientific CONNECTS can bring the full strength from LIMS, CDS, ELN to DMS software. Building on theof its company resources and industry partnerships to strengths of industry leaders allows us to add significantaddressing the challenges faced by customers around the value through comprehensive solutions that help ourworld. With Thermo Scientific SampleManager LIMS and clients improve product quality, lower costs, comply withNextDocs DMS, a personalized, seamless solution was regulatory commitments, and increase overall operationaldeveloped for Nova. Thermo Scientific CONNECTS is excellence. The alliance between Thermo Fisher Scientificcomprised of a combination of Thermo Scientific instru- and NextDocs goes a long way toward addressing thements, LIMS and CDS software, tools and services. With need for regulated content management, integrated work-CONNECTS, the company capitalizes on ongoing partner- flow administration and compliant collaboration in theships with technology leaders including Microsoft, SAP, enterprise setting.Oracle, Enterprise Electronic Laboratory Notebook (ELN)providers like Accelrys, Document Management Systems(DMS) companies like NextDocs, as well as members of the For More Informationcompany’s Global Partner Alliance, to deliver the compre- Visit us on the web athensive solution appropriate for each customer challenge. By offering an end-to-end solution that facilitates Or you can email us atthe integration of various instruments and systems,© 2011 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries.All other trademarks and copyrights are the property of their respective owners. NOVA-CS111Part of Thermo Fisher Scientific